Lead-MSAT (Validation) (Saudi Arabia)

Julphar
Saudi Arabia
Workplace: OnsiteFull timeFunction: Administration & Executive AssistanceExperience: 6-10 yearsEducation: bachelorsSkills: ["Accountability","Communication","Collaboration","Task planning","Risk assessment"]

Lead MS&T and validation activities supporting commercial manufacturing, technology transfer, and site readiness. Serve as the technical bridge across R&D, Technology Transfer, Production, Quality, and Engineering, driving the validation lifecycle (URS, FAT, SAT, IQ/OQ/PQ, re-qualification) and ensuring GMP documentation, data integrity, and ISO 14644 cleanroom qualification compliance. Review protocols/reports/risk assessments, lead investigations with RCA and CAPAs, and coordinate EQMS, calibration, and audit readiness.

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Julphar
Julphar
2 months ago

Lead-MSAT (Validation) (Saudi Arabia)

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Source: Company careers pageValidated by: Fursa AI
Last checked: 1 hour agoStatus: Live

Job Summary

Lead MS&T and validation activities supporting commercial manufacturing, technology transfer, and site readiness. Serve as the technical bridge across R&D, Technology Transfer, Production, Quality, and Engineering, driving the validation lifecycle (URS, FAT, SAT, IQ/OQ/PQ, re-qualification) and ensuring GMP documentation, data integrity, and ISO 14644 cleanroom qualification compliance. Review protocols/reports/risk assessments, lead investigations with RCA and CAPAs, and coordinate EQMS, calibration, and audit readiness.
Location: Saudi Arabia
Workplace: Onsite
Employment Type: Full time
Job Function: Administration & Executive Assistance
Seniority: Sr. Manager level

Key Responsibilities

  • •Lead MS&T activities supporting commercial manufacturing, technology transfer, and site readiness.
  • •Act as the technical bridge between R&D, Technology Transfer, Production, Quality, and Engineering while preparing/reviewing/approving and distributing validation documents.
  • •Maintain validation master plans and validation schedules, ensuring GMP documentation compliance and data integrity requirements.
  • •Execute and oversee the validation lifecycle using the V-Model approach (URS, FAT, SAT, IQ, OQ, PQ, re-qualification) for equipment, CSV, and systems (e.g., Water, utilities, HVAC, electricity, Thermal mapping).
  • •Lead investigations for process deviations/OOS/OOT and atypical results using scientific/statistical root cause analysis, propose CAPAs and process improvements, and support audit/regulatory inspection readiness.

Key Requirements

  • •Lead qualification and validation work in GMP-regulated pharmaceutical manufacturing environments, with 6–10 years of relevant experience and extensive hands-on validation capability.
  • •Strong practical knowledge of cGMP, SFDA, WHO, EU GMP, and ICH guidelines, including GMP documentation practices and regulatory inspection expectations.
  • •Hands-on expertise across the V-Model qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ), re-qualification, and periodic review programs.
  • •Demonstrated experience validating manufacturing equipment/production lines, critical utilities (PW, WFI, HVAC, compressed gases, nitrogen), and cleanrooms per ISO 14644.
  • •Experience with Computerized System Validation (CSV) and EQMS activities such as change control impact assessments, deviation investigations/RCA, CAPA development, and audit support.
Experience:6-10 yearsPharmaceutical manufacturingGMP-regulated environmentsValidationQualificationAseptic processingSterile/non-sterile manufacturing
Education:Bachelor's
Skills:AccountabilityCommunicationCollaborationTask planningRisk assessment
Tech Stack:V-ModelGMPCGMPSFDAWHOEU GMPICH guidelinesISO 14644IQOQPQFATSATURSCAPAALCOA+21 CFR Part 11MS OfficeEQMSElectronic QMS / validation management system

Company Brief

Julphar
Gulf Pharmaceutical Industries, known as Julphar, develops and manufactures a broad range of pharmaceutical products, including generics and healthcare solutions. It serves markets across the Middle East and internationally from its UAE base.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Ras Al Khaimah, United Arab Emirates
Founded: 1980
WebsiteLinkedIn